Biofrontera Inc. Announces FDA Approval of Ameluz for sBCC

What Happened
Biofrontera Inc. (Nasdaq: BFRI) announced on September 14, 2026, via an 8-K (Item 8.01), that the U.S. Food and Drug Administration approved its supplemental New Drug Application for Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, when used with photodynamic therapy (PDT) using the BF‑RhodoLED® lamp series. The approval covers the treatment of superficial basal cell carcinoma (sBCC) in adults. The company furnished a press release dated September 14, 2026 as Exhibit 99.1 to the Form 8-K.

Key Details

• Date filed: September 14, 2026 (Form 8-K, Item 8.01).
• Product: Ameluz® topical gel, 10% (aminolevulinic acid hydrochloride) used in combination with BF‑RhodoLED lamp series PDT.
• Indication approved: Treatment of superficial basal cell carcinoma (sBCC) in adults.
• Press release attached as Exhibit 99.1 to the Form 8-K.

Why It Matters
An FDA approval of this supplemental NDA formally permits Biofrontera to market Ameluz with its BF‑RhodoLED PDT system for sBCC in the U.S., potentially expanding the company’s addressable patient population and commercial opportunities for the product and related device. For investors, this is a regulatory milestone that could impact future product revenues and commercialization plans; the 8-K itself does not disclose financial results or quantify expected sales. The filing shows no other material corporate changes beyond the announcement and the furnished press release.